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NCT07303738 · ClinicalTrials.gov registry record · Phase 4

The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)

A Phase 4 study of Gastrostomy and Aspiration, sponsored by Boston Children's Hospital.

Recruiting
Registry status
Phase 4
Development phase
60
Enrollment target
1
Study location

NCT07303738 is a Phase 4 study of Gastrostomy and Aspiration that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 60 participants, below the 266-participant average among 5 other Gastrostomy trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07303738, a Phase 4 study of Gastrostomy and Aspiration, is actively recruiting participants, sponsored by Boston Children's Hospital.

RECRUITING
Registry status
Phase 4
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

We will perform an acute physiology study comparing three different diets-an amino acid-based formula, a low bile acid-binding blenderized diet, or a high bile acid-binding blenderized diet administered through gastrostomy tube. We will determine the differences in gastric and salivary bile acid concentrations between participants over the 4 hour post-prandial timeframe. Participants who regularly receive an amino acid-based formula will receive an amino acid-based formula during the study and participants who regularly receive a blenderized feed will receive a blenderized feed during the study. Only participants who regularly receive blenderized feeds will be randomized to receive either the high or low bile acid binding blenderized feed.

Interventions

  • DRUG amino acid based formula (e.g. Elecare Jr)
  • DRUG low bile acid binding blenderized diet (e.g. Kate Farms)
  • DRUG high bile acid binding blenderized diet

Study Locations (1)

Massachusetts

  • Boston Children's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-12-01
Est. Completion 2030-08
Phase Phase 4

Sponsor

Boston Children's Hospital

462 total trials

What the Registry Record Tells You About NCT07303738

The ClinicalTrials.gov registry entry for NCT07303738 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 266-participant average among 5 other Gastrostomy trials with a reported enrollment target (77% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Gastrostomy appearing as the primary indexed condition, and to 3 interventions - of which amino acid based formula (e.g. Elecare Jr) is the first listed.

NCT07303738 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT07303738 about?

NCT07303738 is a clinical study titled "The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)". We will perform an acute physiology study comparing three different diets-an amino acid-based formula, a low bile acid-binding blenderized diet, or a high bile acid-binding blenderized diet administered through gastrostomy tube. We will determine the differences in gastric and salivary bile acid con...

What is the current status of trial NCT07303738?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2025-12-01. Estimated completion is 2030-08.

What conditions does trial NCT07303738 study?

This clinical trial studies the following conditions: Gastrostomy, Aspiration, Feeding Difficulties.

What interventions are being tested in trial NCT07303738?

The interventions under investigation include: amino acid based formula (e.g. Elecare Jr) (DRUG), low bile acid binding blenderized diet (e.g. Kate Farms) (DRUG), high bile acid binding blenderized diet (DRUG).

Who is sponsoring clinical trial NCT07303738?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07303738 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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